Clinical Research Coordinator

OneOncology; Fountain Valley (CA); On-site; USD 75,000 - 80,000; Full time

Job summary

The Los Angeles Cancer Network is seeking a Clinical Research Coordinator to work independently coordinating studies, screening potential patients for protocol eligibility, presenting non-medical trial concepts, and participating in the informed consent process.

You will maintain accurate source documents and data collection, enter and report information, respond to sponsor queries, and help plan strategies to increase patient enrollment.

Qualifications

• BA/BS degree preferred; 1 year minimum experience in clinical research coordination.
• ACRP/SoCRA certification preferred.
• Oncology/Hematology experience preferred.

Responsibilities

• Coordinate study activities including screening and informed consent.
• Schedule patients for visits and procedures.
• Document CRFs with changes in patient condition and adverse events.
• Maintain accurate source documents and data entry.
• Collaborate with IRB and sponsor queries.
• Ensure FDA/IRB compliance and GCP adherence.
• Assist with patient billing and reconciliation.
• Present accrual data and workload at staff meetings.

Skills

Study coordination

Patient scheduling

CRF documentation

Source documents

Data collection

Monitoring activities

Data quality

IRB coordination

Billing reconciliation

GCP compliance

HIPAA compliance

Training staff

SOP development

Enrollment strategies

Quality improvement

Research opportunities

Education

BA/BS degree

ACRP/SoCRA certification

Oncology experience

Hematology experience

Job description

The mission of The Los Angeles Cancer Network is to provide unparalleled care to each patient that comes through our doors. We offer individualized treatment using the most recent and relevant proven advances in cancer care, curated with deliberation and compassion. LACN is committed to educating and supporting our patients and their families through every step of the way. We deliver a unique approach for every patient to ensure they receive treatment best suited to their condition, age, and other important factors. We do this by participating in important clinical research, encouraging screenings for early detection, and providing innovative treatment. We are proud to be at the forefront of cancer research through our partnership with OneOncology.

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description:

The Clinical Research Coordinator works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).

Essential Functions:

The following reflects management’s definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time with reasonable accommodations.

• Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process.
• Scheduling of patients for research visits and procedures.
• In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
• Maintains accurate source documents related to all research procedures.
• Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries.
• Schedules and participates in monitoring and auditing activities.
• Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings.
• Notifies direct supervisor about concerns regarding data quality and study conduct.
• Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• May involve in assisting with patient research billing and reconciliation.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• May coordinate training and education of other personnel.
• May participate in centralized activities such as auditing, Standard Operating Procedure development, etc.
• Responsible to plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency.
• May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
• May identify new research opportunities and present to investigators
• Participates in required training and education programs.

Key Competencies:

• Strong customer service background, preferably in a healthcare setting.
• Excellent written and verbal communication skills.
• Knowledge of computer/telephone support, preferably in the healthcare industry.
• Ability to resolve customer issues calmly and professionally with diplomacy and tact.

Education and Experience:

• BA/BS Degree – Preferred.
• ACRP/SoCRA (or equivalent) certification preferred.
• 1 year minimum of clinical research coordination experience, required
• Previous Oncology/Hematology experience preferred.

Additional Requirements:

• Great Customer Service Skills.
• Knowledge of medical terminology, specifically in Oncology/Hematology.
• Able to travel to satellite clinics when necessary.
• Must be willing and able to lift up to 25 pounds.

Compensation:

• Pay range from $75k to $80k, depending on experience and education.